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临床试验/NCT07383623
NCT07383623招募中不适用

THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN: A RANDOMIZED CONTROLLED TRIAL

Ayşegül Kanık1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
1
主要终点
postpartum perineal pain

研究概览

简要总结

This randomized controlled study aims to evaluate the effects of skin closure using surgical staplers compared with conventional skin sutures on postoperative pain and wound healing in primiparous women undergoing episiotomy repair after vaginal delivery.

Primiparous women who require episiotomy during vaginal birth will be randomly assigned to one of two groups: skin closure with staples or skin closure with sutures. Postpartum pain levels and wound healing outcomes will be assessed and compared between the two groups.

The results of this study are expected to contribute to evidence-based decisions regarding optimal skin closure techniques in episiotomy repair.

详细描述

Episiotomy is one of the most commonly performed obstetric interventions during childbirth. Although it shares similar characteristics with spontaneous second-degree perineal tears, episiotomy was routinely performed for many years. However, routine episiotomy practices began to be questioned in the late 1970s and 1980s, and its use declined during the 1990s. Factors contributing to this change include increased health awareness among women, the natural childbirth movement, professional competition, and the widespread adoption of evidence-based practices.

Pain associated with episiotomy is a significant issue that negatively affects women's quality of life in the postpartum period. A woman's request for analgesia is considered a medical indication for pain management. Inadequate pain control reduces the effectiveness of therapeutic interventions. Episiotomy-related pain decreases maternal comfort, negatively affects mother-infant bonding, reduces breastfeeding success, and may even influence women's childbirth preferences due to fear of labor and episiotomy pain.

The ideal method for episiotomy repair should be fast, easy to perform, cause minimal tissue trauma, and result in minimal postpartum pain and dyspareunia. Closure techniques that minimize skin trauma reduce inflammation and scarring by limiting the introduction of foreign materials. Various techniques have been proposed for postpartum episiotomy repair, including non-suturing of the incision, continuous locking sutures, and interrupted non-locking sutures. Regardless of the technique used, successful tissue approximation is associated with less pain and wound infection, better cosmetic outcomes, and shorter hospital stays.

In recent years, traditional repair methods have increasingly been replaced by modern techniques such as skin staples, tissue adhesives, and adhesive strips. Skin staples, one of these modern methods, are described as a faster and more reliable repair technique. Due to their fixed depth and uniform structure, staples provide equal wound tension, which is thought to reduce pain and promote wound healing in episiotomy skin repair.

The aim of this study is to determine the effects of using staples versus surgical sutures in episiotomy skin repair on postpartum localized pain and wound healing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Term pregnancy (≥ 37 weeks)
  • Low-risk pregnancy (no obstetric risk factors)
  • Not receiving oxytocin induction during latent or active labor
  • Singleton pregnancy with a live fetus
  • No psychiatric disorder
  • No substance abuse
  • Primiparous women (first vaginal birth)
  • Presence of 1st or 2nd degree perineal tear
  • Able to read, understand, and voluntarily provide written and verbal informed consent.

排除标准

  • Apgar score < 7 at 1 minute and/or 5 minutes
  • Neonatal anomaly
  • Use of >10 mL analgesic during episiotomy repair beyond routine practice
  • Vaginal infection or vaginal lesion
  • Maternal conditions impairing wound healing (e.g., diabetes mellitus, immunosuppression, coagulation disorders)
  • 3rd or 4th degree perineal tear
  • Shoulder dystocia / difficult delivery

研究组 & 干预措施

stapler skin closure group

Experimental

Episiotomy repair is performed using surgical staplers for skin closure in primiparous women.

干预措施: stapler skin closure (Device)

Absorbable suture group

Experimental

Skin closure of episiotomy is performed using absorbable sutures.

干预措施: absorbable suture group (Procedure)

结局指标

主要结局

postpartum perineal pain

时间窗: At 6 hours, 24 hours and 7 days postpartum

Perineal pain severity will be assessed using the Visual Analog Scale (VAS) following episiotomy repair. The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain severity.

次要结局

  • Episiotomy wound healing(10 days postpartum)

研究者

发起方
Ayşegül Kanık
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ayşegül Kanık

MIDWIFE

Ege University

研究点 (1)

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